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NCT00001948 · ClinicalTrials.gov registry record

A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy

A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
70
Enrollment target

NCT00001948: Completed study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00001948 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 70 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001948 has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
70 participants
Enrollment target

Study Summary

This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One group will receive continuous treatment over the entire 88-week study period; the other will have interruptions in therapy over the same time period. Patients enrolled in the National Institute of Allergy and Infectious Disease's trial, "Immunologic and Virologic Studies of Intermittent versus Continuous HAART \[highly active antiretroviral therapy\] in the Treatment of HIV Disease," may participate in this study. At periodic intervals for a total of 7 times during the 88-week trial, this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires: 1. MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being. Survey questions are related to the ability to perform work and daily living activities, mood and state of mind, limitations on social activities, ability to concentrate, energy level, pain level, general quality of life, etc. 2. Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors, including appetite, nausea, breathing, cough, pain, insomnia, fatigue, bowel problems, concentration, appearance, and outlook. Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches.

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 1999-12
Est. Completion 2002-02

What the finished NCT00001948 record still lists

NCT00001948 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00001948 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001948 about?

NCT00001948 is a clinical study titled "A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy". This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection. One group will receive continuous treatment over the entire 88-week study period; the other will have interruptions in...

What is the current status of trial NCT00001948?

This trial is currently completed. The enrollment target is 70 participants. The study started on 1999-12. Estimated completion is 2002-02.

Who is sponsoring clinical trial NCT00001948?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00001948, the US trial registry maintained by the National Library of Medicine. NCT00001948 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.